Laboratory developed tests play an essential role in diagnosing and treating many of the conditions that affect pediatric patients. Join the Association for Diagnostics & Laboratory Medicine (formerly AACC), the Children’s Hospital Association, and leading experts in laboratory medicine and pediatric health for a discussion about the use of laboratory developed tests in pediatric care, and a duplicative rule issued by the Food and Drug Administration (FDA) that threatens access to these vital tests.
Speakers will address:
- The key role that laboratory developed tests play in diagnosing and treating pediatric conditions for which no commercial tests exist, particularly in newborns
- The significant negative impact that the FDA’s laboratory developed tests rule will have on children’s hospitals, clinical laboratories, and pediatric care overall
For a number of reasons, there isn’t much financial incentive for manufacturers to develop pediatric tests, which means there are few FDA-authorized tests for children on the market. Fortunately, children’s hospital laboratory directors are highly educated and are able to use their extensive knowledge to create laboratory developed tests that meet the needs of their patients. These laboratory developed tests are used to diagnose conditions ranging from rare diseases to the potentially life-threatening genetic conditions that every newborn is screened for.
Clinical labs such as the ones that serve children’s hospitals are stringently regulated by the Centers for Medicare & Medicaid Services (CMS). However, on May 6, 2024, the FDA published a rule that will place laboratory developed tests under dual FDA-CMS oversight, a move that will likely cause laboratories to scale back on or stop performing these essential tests.
This briefing will explore the importance of laboratory developed tests, how they’re currently regulated, and why placing these tests under duplicative FDA oversight will limit patient access to them without improving care for our most vulnerable patient population — children.
When: Luncheon briefing: 12 – 1 p.m., Thursday, February 20
Where: Room 2045, Rayburn House Office Building
Who:
- Moderators: Dennis J. Dietzen, PhD, DABCC, FAACC, Megan Dishop Chair of Pathology and Laboratory Medicine, Phoenix Children’s Hospital
- Meghan Delaney, DO, MPH, chief, pathology & laboratory medicine division, Children’s National Hospital
- Stephen R. Master, MD, PhD, chief, division of laboratory medicine, Children’s Hospital of Philadelphia
RSVP: Email Christine DeLong, ADLM associate director, communications & PR at [email protected].
About the Association for Diagnostics & Laboratory Medicine (ADLM) Dedicated to achieving better health through laboratory medicine, ADLM (formerly AACC) brings together more than 70,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of progressing laboratory science. Since 1948, ADLM has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit .
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